Background: While breast biopsy remains the gold standard for diagnosis of suspicious lesions, a large proportion of biopsy specimens reveal a benign result. Therefore, a noninvasive and reliable method to identify low-risk lesions would be a valuable tool.
Methods: We assessed the application and diagnostic performance of elastography for the characterization of breast lesions in patients referred for biopsy. Subjects referred for ultrasound-guided biopsy of sonographically apparent breast lesions were included in this study. The Hitachi Hi-Vision 900 ultrasound was used to generate index test results for elastography scoring (ES) and for strain ratio (SR) measurement. Sensitivity, specificity, and positive and negative predictive values were determined using pathologic results from 14-gauge core needle biopsy as the reference standard.
Results: A total of 310 lesions in 288 patients were included in this series. Of these 310 lesions, 223 (72%) were benign and 87 (28%) were malignant. Sensitivity was 0.76 for ES and 0.79 for SR. Specificity was 0.81 for ES and 0.76 for SR. Positive predictive value was 0.60 for ES and 0.57 for SR. Negative predictive value was 0.90 for ES and 0.90 for SR. SR values for malignant lesions were significantly higher (median ratios 10.5 and 2.7, respectively, P < .001).
Conclusions: While the initial clinical performance of elastography imaging shows potential to reduce biopsy of low-risk lesions, a large-scale trial addressing appropriate patient selection, diagnostic parameters, and practical application of this technique is necessary prior to widespread clinical use.